More than half of all people with diabetes around the world are affected by diabetic peripheral neuropathy, according to the International Diabetes Federation. There is no prescription therapy in the United States currently approved to treat the underlying process of microvascular damage that leads to microvascular complications such as diabetic peripheral neuropathy. LY333531, according to pre-clinical data, is a specific inhibitor of PKC b, an enzyme that has been implicated in the underlying process of microvascular (small blood vessel) damage that leads to diabetic microvascular complications. PKC b Inhibitor is being studied as a possible treatment for multiple diabetic microvascular complications, including diabetic retinopathy and diabetic peripheral neuropathy.
Based upon results collected to date, Lilly will conduct three new global registration trials for the study of diabetic peripheral neuropathy increasing to six the current number of Phase 3 trials with LY333531 for the treatment of diabetic microvascular complications. The three new trials will begin this year. Lilly plans to file for regulatory approval for the treatment of symptoms of diabetic peripheral neuropathy in 2004 in the United States.
Lilly is also investigating PKC b Inhibitor as a potential treatment for diabetic retinopathy and diabetic macular edema microvascular complications that can lead to blindness. Registration trials are being conducted, and Lilly plans to file for regulatory approva
Contact: Morry Smulevitz
Eli Lilly and Company